Update on the INESSS-ONF Clinical Practice Guideline for the Rehabilitation of Adults with Moderate to Severe Traumatic Brain Injury in Canada - Development and Implementation

Mark Bayley, MD, FRCPC; - Toronto Rehabilitation Institute & University of Toronto, OntarioEmail: mark.bayley@uhn.ca

Bonnie Swaine, PhD, Center for interdisciplinary research in rehabilitation (CRIR) & Université de Montréal, Québec

Email: bonnie.swaine@umontreal.ca

An inter provincial partnership

INESSS-ONF Guideline Development Team:

Corinne Kagan, BA., BPS Cert. – ONF Catherine Truchon, Ph.D., MSc. Adm – INESSS Shawn Marshall, MD, MSc (Epi), FRCPC, Ottawa

Hospital Research Institute & University of Ottawa Marie-Eve Lamontagne, Ph.D. Université Laval, CIRRIS Project coordinators

– Ailene Kua, M.Sc (ONT), Anne-Sophie Allaire, M.Sc (QC) & Pascal Marier-Deschenes (QC)

+++ Collaborators

Aim of Presentation

To provide an update of the development and implementation of the INESSS-ONF clinical practice guideline (CPG) for moderate to severe traumatic

brain injury

Learning objectives

Recognize the topics and clinical resources contained in the INESSS-ONF clinical practice guideline for use with persons with moderate to severe TBI;

Identify relevant priorities for improving the quality and efficacy of TBI rehabilitation;

Identify components of the INESSS-ONF guideline website for future navigation.

Plan of the presentation

Review the concept of clinical practice guidelines: why they are needed and who uses them

Provide background to the development and adaptation of the CPG

Provide an overview of the content of the guidelines and highlight some of its recommendations using examples (clinician/manager & person with TBI/family member)

Discuss the implementation plan for Québec and Ontario

What is a Guideline?

• What is evidence-based practice?

• Why are guidelines needed?

• Who uses guidelines?

Evidence-Based Practice

• The conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients. (Sackett, 1996, BMJ 312, 71-72)

• Clinicians who want to use EBP must find trusted and readily accessible sources for the best evidence, relevant to their practice area.

Clinical Practice Guidelines

Systematically developed statements that help clinicians and patients identify and deliverappropriate health care

Clinicalpractice

guidelines

Scientificevidence

Clinicalexpertise

Patients’ opinions and preferences

Systematic production process

CPGs can:• Identify the nature, volume and quality of research

evidence supporting clinical recommendations • Improve decision making and ultimately, clinical outcomes • Improve consistency of care• Inform patients and other stakeholders regarding the

treatment they should be receiving• Influence health policy to enhance treatment efficiency and

access to services

Why Guidelines?

Keris V, Lavendelis E, Macane I. World J Surg. Jun 2007;31(6):1352-1355

Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Bmj. Feb 20 1999;318(7182):527-530

Review and evaluation of existing CPGs

May – Nov. 2013

Validation of the end-users’ needs and

expectations

Nov. 2013 – Jan. 2014

1 2

Synthesis of all existing documentation and

evidence

Mar. – Nov. 2014

3

Consensus process amongst experts

Nov. 2014

4

Adaptation of the recommendations and

production of the guidelines

Nov. 2014 – May 2015

5

INESSS-ONF Guideline

Guideline Development

and Adaptation

Final Product

Guideline Development Process

Presentations /

Publications

Implementation/Evaluation:

INESSS-ONF Guideline

May 2015– May 2016

Fall 2016

External Review

INESSS-ONF Guideline:

Final Product

Refinement

Agreement

Further inputfrom panel experts

Validation of the end-users’ needs and expectations

Survey of end-users needs & expectations – 53% were not aware of any CPGs for the rehabilitation of adults with

moderate and severe TBI

Identification of relevant topics

– Comments and suggestions regarding new elements

Key implementation process elements– Want training and think use of the CPG by the colleagues/team would

facilitate implementation

Validation of the end-users’ needs and

expectations

Nov. 2013 – Jan. 2014

Stakeholder consultation:Guidelines topics

Guidelines topics – early recovery

Sharing Survey Results

GUIDELINE CONSENSUS CONFERENCENOV 26 & 27, 2014

Consensus processamongst experts

Nov. 2014

Expert Panel

PROJECT TEAM

• Anne-Sophie Allaire

• Mark Bayley

• David Caplan

• Mario De Bellefeuille

• Corinne Kagan

• Ailene Kua

• Shawn Marshall

• Bonnie Swaine

• Catherine Truchon

CLINICIANS

• Mélanie Bérubé

• Chantal Boutin

• Nora Cullen

• Jehane H. Dagher

• Carol DiSalle

• Soumiya El Fassi

• Elizabeth Farquharson

• Melissa Felteau

• Connie Ferri

• Josée Fortier *

• Stéphane Gagnier

• Shaun Gray

• Marie-Clothilde Grothé

• Denise Johnson

• Danièle Labrèche

• Marie-Claude Lemay

• Carolyn Lemsky

• Geneviève Léveillé *

• Heather MacKenzie

• Scott McCullagh

• Suzanne McKenna

• Laura Moll

• Nancie Poulin

• Colin Pryor

• Laura Rees *

• Marie-Claude Roberge

• Robert Teasell *

• Alexis Turgeon

• Diana Velikonja

• Penny Welch-West

MANAGERS

• Mitra Feyz

• Patsy McNamara

• Sylvie Valade

• John Zsofcsin *

• Debbie Furlotte *

* Advisory Committee Members

RESEARCHERS

• Carolina Bottari

• Angela Colantonio

• Élaine De Guise

• Robin Green

• Shannon Janzen

• Marie-Josée Lever

• Michelle McKerral

• Marie-Christine Ouellet

• Mary Stergiou-Kita

DECISION-MAKERS and

CONSUMER ASSOCIATION

REPRESENTATIVES

• Gilles Bourgeois

• Jonathan Jean-Vézina

• Danie Lavoie

• Charissa Levy

• Jean-François Lupien

• Ruth Wilcock

Recommendations Matrix

Revising Recommendations / Developing Novel Recommendations

Level of evidence used by existing guidelines varies depending on the individual methodology.

To achieve consistency among the recommendations, the level of evidence for each recommendation was assigned the INESSS-ONF grade.

INESSS-ONF LEVEL OF EVIDENCE

ARecommendation supported by at least 1 meta-analysis, systematic review, or randomized controlled trial of appropriate size with relevant control group.

BRecommendation supported by cohort studies that at minimum have a comparison group, well-designed single subject experimental designs, or small sample size randomized controlled trials.

CRecommendation supported primarily by expert opinion based on their experience though uncontrolled case series without comparison groups that support the recommendations are also classified here.

What Makes a Good Recommendation

A good recommendation should :

– Be short

– Be clear

– Specify who

– Specify what

– Specify how

– Specify when

– Be operationalizable

– Be implementable

– Be measurable

262 RECOMMENDATIONS DIVIDED IN TWO SECTIONS

SECTION I

Components of the Optimal TBI Rehabilitation System”

68 recommendations: 32 new & 36 existing

SECTION II

Assessment and Rehabilitation of Brain Injury Sequelae

194 recommendations: 87 new & 107 existing

Finalized set of recommendations

Indicators & Outcome measures

Development of Indicators

1. How will you know that people have followed CPG? • What are your Process Indicators? (Measurement of

presence/absence/timing/quality of care process)

2. How will you know that the person with brain injury is better because of the implementation of CPG?

• What are the Clinical Outcomes Measures? (Outcome measures typically measure impairments, activity level, roles in life or quality of life domains)

Process Indicators (Examples)

Recommendation: People with severe TBI who have not recovered independently in self care should be admitted to comprehensive inpatient rehabilitation as soon as they are medically stable and able to participate.

Potential Indicators:

• Proportion of people with severe TBI ( i.e. GCS<9) referred to inpatient rehabilitation

• Average time from injury to onset of inpatient rehabilitation

Recommendation: All patients with TBI should be screened for depression during inpatient rehabilitation and at all transitions.

Potential Indicators:

• Proportion of TBI patients admitted to inpatient rehab with documented depression screening tool used

Outcome Measures

Measurement at Patient level of recovery from brain injury

Cognitive recovery as measured by the Wisconsin Card Sorting Test

Physical recovery - 6 minute walk test Quality of Life measures Glasgow Outcome Scale

INESSS-ONF GuidelineThe website

Let’s say you are a

Manager of an ABI program wanting to improveyour program or put in place recommendations for your program…

You are wondering how to expedite referrals to inpatient rehab and measuring your teams performance

Two Key Sections

Components of the Optimal TBI Rehabilitation System

– target audience is health system leaders who are designing system

Assessment/Rehabilitation of TBI Sequelae

– specific strategies targeted at clinicians

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Part 1 General Principles for Organization of Rehabilitation Services Specialized Health Professional Training Case Management Specific Risk Management Rehabilitation in the Acute Phase Management of Altered of Level of Consciousness Transfer to Rehabilitation Services Intensive SubAcute Rehabilitation Models of Traumatic Brain Injury Inpatient Rehabilitation Intensity and Duration of Treatment Discharge to the CommunityRehabilitation to promote Reintegration/ Participation in Community Roles Post-discharge Follow-up and Support Models of Community Rehabilitation Intensity and Duration of Community Based Therapy Optimizing Performance in Daily Living Tasks Leisure and Recreation Driving Vocational/ Education Caregivers and FamiliesBrain injury Education and AwarenessCapacity and Consent

27

Two key types of recommendations

➢ Fundamental Recommendations elements that rehabilitation programs need to have in

place in order to build the rest of the system properly primarily for program managers and their leaders as they

reflect upon the service conditions for optimal rehabilitation provision.

➢ Priority Recommendations clinical practices or processes deemed most important to

implement and monitor during rehabilitation practices most likely to bring on positive outcomes for

people with TBI.

Two main parts…

Format of the Guideline

C. Intensive Sub-Acute Rehabilitation

RATIONALE SYSTEM IMPLICATIONS

PERFORMANCE MEASURES IMPLEMENTATION RESOURCES AND KNOWLEDGE TRANSFER TOOLS SUMMARY OF THE EVIDENCE

Format of the Guideline

RATIONALE - +

Traumatic brain injury results in complex physical, emotional and cognitive changes. There is solid evidence that rehabilitation can improve outcomes however because of complexity a large interprofessional team is required. There is also evidence that earlier rehabilitation will result in better outcomes than delayed. Because of the emotional changes, a quiet environment may reduce the incidence of challenging behaviours. Furthermore, each individual has unique needs therefore a case manager can coordinate the program to ensure that the person’s goals are met and to facilitate transition back into normal living.

Format of the Guideline

SYSTEM IMPLICATIONS - +

There is a need for coordination between acute care and rehabilitation teams. Processes for referral to rehabilitation need to respond quickly. Development of clinical pathways requires clinician engagement in ensuring reasonable approach. Traumatic brain injury rehabilitation teams require adequate staffing to provide daily therapy. Rehabilitation should be provided in a secure environment where cognitively impaired individuals will not wander off

Format of the Guideline

PERFORMANCE MEASURES - +

Proportion of Patients admitted to acute care who access inpatient rehabilitation

Average time post injury to admission to inpatient rehabilitation

Proportion of patients assessed and treated by each discipline (PT,OT etc)

Total number of hours of therapy during inpatient

Average number of direct therapy hours per day

Proportion of people with TBI who have a case manager

LOS

Change in FIM

Fim efficiency ( Change in FIM/LOS)

Format of the Guideline

IMPLEMENTATION RESOURCES AND KNOWLEDGE TRANSFER TOOLS

Recommendations

Recommendations

Type of recommandation: Priority, Fundamental, Regular

Recommandation

Three levels of evidences: A, B and C

Rationale

System implications

Key indicators

Summary of Evidence

Let’s say you are a

Clinician or person with TBI wanting to know whatis the best treatment for memory problems…

Part. 2 Assessment/Rehabilitation of TBI Sequelae

Principles of Assessment of the Person with TBI Altered State of Consciousness Cognition Interventions Cognitive Communication Dysphagia and Nutrition Interventions Motor Function and Control Visual assessment and Rehab Fatigue and Sleep Disorders Pain and Headaches Psychosocial/Adaptation Issues Neurobehavioral / Emotional Mental Health Issues Special Challenges / Concomitant Issues e.g. Drug and Alcohol Use

46

Format of the Guideline

C. Intensive Sub-Acute Rehabilitation

RATIONALE SYSTEM IMPLICATIONS

PERFORMANCE MEASURES IMPLEMENTATION RESOURCES AND KNOWLEDGE TRANSFER TOOLS SUMMARY OF THE EVIDENCE

Implementing our guidelines

Implementation/Evaluation:

INESSS-ONF Guideline

May 2015– May 2016

Fall 2016

Fundamental and priority recommendations too numerous to implement

Surveyed 44 programs (n= 26 in Quebec, n= 18 in Ontario) about current situation, their opinions about priorities and feasibility of implementing recommendations (including potential obstacles)

Identify a subset of recommendations not yet implemented in rehabilitation but of high priority and feasible to implement

The implementation of the CPG

Pre-Implementation Survey

The implementation of the CPG

Collaborative process

– Clinicians, managers, policy makers

Evidence-based implementation process

– Strategies, stakeholders, timing, etc.

– Tools (workshops, auditing) & having designated time to read the guideline and familiarize with it

Pilot projects in a few settings

An ImplementationStrategy

Summary

CPGs are important to evidence-based practice

CPG has been adapted to improve TBI rehabilitation in Ontario and Québec

Website launch of CPG

Implementation of the CPG